The Effectiveness of Personalized Colorectal Cancer Screening Based on Fecal Hemoglobin Concentration (PERFECT-FIT)

June 14, 2022 updated by: Esther Toes-Zoutendijk
We aim to improve the yield and effectiveness of the Dutch colorectal cancer screening program by using a personalized screening strategy based on fecal Hemoglobin concentration in previous screening round for participants with a negative fecal immunochemical test (FIT).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A fecal Hemoglobin concentration just below the cut-off of the fecal immunochemical test (FIT) is associated with a higher risk for the detection of colorectal cancer of advanced adenomas at consecutive screenings. Individuals with these higher fecal Hemoglobin concentrations may benefit from shorter screenings interval, whereas individuals without any fecal Hemoglobin concentrations could benefit from longer screening intervals.

A randomized controlled trial will be conducted within the national CRC screening program among individuals with a negative FIT in the previous screening round. Individuals in the intervention arm will receive an invitation after 1, 2, or 3 years depending on their fecal Hemoglobin concentration in the previous round, whereas individuals in the control arm will receive an invitation after 2 years according to current practice.

The overall aim of this study is to improve the balance between harms and benefits of CRC screening, by using a personalized approach based on fecal Hemoglobin concentration at previous screening. More specifically, this study has three goals:

  1. Evaluate the superiority of risk-based FIT screening in a randomized controlled study embedded in a running national screening program;
  2. Evaluate the feasibility and acceptability of risk-based FIT screening in a national screening program;
  3. Estimate the long-term effect of personalized screening versus uniform screening.

To achieve these goals a randomized controlled trial, focus groups and microsimulation modelling will be conducted.

Study Type

Interventional

Enrollment (Anticipated)

20000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

52 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previous negative FIT (below the cut-off of 47 microgram per gram feces)

Exclusion Criteria:

  • Previously tested with FIT cut-off of 15 microgram per gram feces

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
Participants receive a personalized screening invitation interval (1,2 or 3 years) based on their fecal Hemoglobin concentration of the negative fecal immunochemical test in previous round.
Other: Personalized screening invitation interval
Time to receive the next invitation for fecal immunochemical testing screening, will depend based on individuals risk determined by fecal Hemoglobin concentration
No Intervention: Control arm
Participants receive a standard screening invitation interval (2 years).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of colorectal cancer and advanced adenomas
Time Frame: 6 months after the last invitation
Number of colorectal cancers and advanced adenomas per screened individual
6 months after the last invitation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: 6 months after the last invitation
Number of individuals participating in personalized FIT screening
6 months after the last invitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Esther Toes-Zoutendijk

Investigators

  • Principal Investigator: Iris Lansdorp-Vogelaar, PhD, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

June 14, 2022

First Submitted That Met QC Criteria

June 14, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

June 21, 2022

Last Update Submitted That Met QC Criteria

June 14, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WO 19-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Outcomes of the study will be stored in the national screening information system, owned by a third-party sources. Data cannot be publicly shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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